In a world of highly complex medical technology, the risk of usage errors and safety gaps is constantly increasing. The process of Post-Market Surveillance (PMS) is essential to ensure the continued safety and performance of medical devices.
However, implementing an effective PMS poses challenges for many companies: Regulatory requirements are complex, implementation is laborious, yet essential for patient safety and product quality.
We help you to shed light on this.
Basics of Post-Market Surveillance
Post-market surveillance, or PMS for short, is a systematic, proactive process for monitoring medical devices after their market launch. The central objective is to minimize risks and continuously improve product safety. It is a regulatory obligation for manufacturers of medical devices that not only serves to ensure compliance with regulations, but also represents a quality feature.
The PMS is based on legal requirements, such as those set out in the MDR and IVDR. Manufacturers must demonstrably collect and evaluate data on the use of their products and take the resulting measures.
Article 83 of the MDR states: “For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner appropriate to the risk class and the nature of the device.”
This procedure is crucial for identifying and assessing potential risks, but also for recognizing opportunities for product improvement and innovation.
Effective post-market surveillance not only enables early detection of problems, but also promotes user confidence in the medical devices. Data from the PMS flows into future versions and in some cases back into the life cycle of the products, thus supporting product development and contributing to increased patient safety.
Definition and goals
Post Market Surveillance (PMS) is a systematic process that aims to continuously monitor and evaluate the safety and performance of medical devices after their market launch. It is an essential pillar in the risk management cycle and necessary for maintaining product conformity and quality.
Within the PMS, information on the practical use of medical devices is systematically collected, evaluated and used to identify potential risks and take appropriate measures to increase product safety. It also supports the continuous improvement of product designs and the associated processes, thereby contributing to optimized patient care.
An effective PMS system can strengthen brand reputation and increase user confidence.
PMS integrates medical knowledge and user feedback into the development process, resulting in a more effective and user-friendly medical device design. It not only serves to fulfill legal requirements, but also provides a solid basis for strategic decisions and ensuring the company’s long-term success in the market.
Legal framework in the EU
The approval of medical devices is regulated by the EU.
The regulatory environment for medical devices in the European Union is becoming increasingly complex. The MDR and IVDR, which have been in force since May 2021, define the legal framework for the supply, placing on the market and surveillance of medical devices. The MDR and IVDR increase the requirements for post-market surveillance in order to increase the level of protection for patients and users. However, the implementation of this regulation is a challenge for manufacturers due to the detailed documentation and reporting requirements.
The MDR requires a continuous risk assessment.
An essential aspect of the MDR is the expansion of post-market surveillance. Specifically, this means that manufacturers of medical devices are obliged to continuously collect and analyze data on the performance and safety of their products. This includes feedback from users, incidents and scientific publications. The knowledge gained must then be incorporated into the life cycle of the product to ensure safety and performance.
The manufacturer must assess at least once, based on the data obtained, whether there has been a change in the benefit-risk ratio of their product. If his assessment shows that there is a need for a measure, then he MUST implement it and adapt processes within the product life cycle accordingly.
Active monitoring and regular reporting are mandatory.
In addition to continuous data analysis, the MDR stipulates that manufacturers must publish regular safety reports. The Periodic Safety Update Report (PSUR) is an essential part of the PMS and must be updated at least every two years for Class IIa devices and annually for Class IIb and III devices. These reports are reviewed by the competent authorities and are publicly accessible.
Differentiation from market observation
Post-market surveillance is more strictly regulated in detail than general market surveillance. The focus here is on security-relevant information, which has the highest priority.
In contrast, market surveillance is often focused on marketing.
Market observation is also concerned with the collection of data, but is less concerned with risk management and quality.
While market monitoring tends to evaluate the acceptance and success of a product on the market, PMS focuses on safety and performance after market launch.
PMS identifies weaknesses, initiates improvements and thus proactively addresses potential risks for the user.
Implementation in day-to-day business
The effective implementation of post-market surveillance in operational processes requires a systematic approach and a continuous improvement culture. It is important that all relevant data sources such as customer feedback, clinical evaluations or information from quality management systems are included and analyzed. A structured process for data evaluation and interpretation must be established in order to identify the need for action at an early stage and to continuously optimize the safety and performance of medical devices.
Article 83 of the MDR states: “For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.”
In addition, the documentation of all PMS activities is essential for complete traceability in order to meet regulatory requirements and create the basis for a trusting relationship with authorities and end users.
Setting up an internal PMS system
A key aspect for the effectiveness of Post Market Surveillance is the implementation of an internal PMS system that is carefully embedded in the corporate structures. Such a system should be based on a precise PMS strategy that defines relevant processes, clear responsibilities and compliance with regulatory requirements.
Efficient workflows and communication channels are essential for the PMS system. This ensures that information flows seamlessly and can be processed quickly.
The selection of suitable software solutions supports data collection and analysis. Integration into existing IT systems facilitates the access and exchange of critical data.
To ensure continuous data evaluation, the internal PMS system must include regular reviews and updates. It is advisable to set up a PMS committee with multidisciplinary members dedicated to the regular review of the collected data.
The following roles are represented here:
- PRRC (at least in a supervisory function): Persons responsible for compliance with regulatory requirements (PRRC) could, for example, act as Regulatory Affairs Manager or Regulatory Compliance Specialist.
- RM: Risk Manager or Risk Management Specialist, responsible for risk management in the company.
- QC/QA: Quality Control/Quality Assurance, includes positions such as Quality Control Manager or Quality Assurance Specialist, who are responsible for ensuring product quality.
- Clinician, if applicable: A clinician could hold various positions in the clinical area, such as Clinical Research Associate or Clinical Trial Manager, depending on the specific needs of the organization.
Additional roles may also be required depending on the size of the company and product portfolio, such as:
- PM: Project manager who coordinates and manages projects.
- QM: Quality Manager, who is responsible for quality management in the company.
- RnD: Research and Development, including roles such as Research Scientist or Development Engineer.
- Prod: Production Manager or Production Manager, responsible for production processes.
- Purchasing: Purchasing Manager or Purchasing Specialist, responsible for the procurement of materials and services.
This list is not exhaustive and may vary depending on company structure and needs.
Effective PMS also requires a well thought-out risk management strategy that responds to PMS data. This includes constant monitoring of product safety and performance to identify and minimize risks at an early stage.
Ultimately, it is essential that the PMS system reflects the provisions of the MDR (Medical Device Regulation) and is continuously adapted to changing regulatory requirements. Compliance must be the top priority at all times.
Data sources and information flow
Various sources contribute to data collection, including clinical studies, customer feedback and product observations after market launch. This multi-dimensionality of the information flow is crucial for a holistic overview of product performance and safety.
Efficient Post-Market Surveillance (PMS) relies on a wide range of data sources. Market research, spontaneous incident reports, scientific literature and internal feedback from quality and manufacturing processes provide important insights. Associated databases and registers, such as the German BfArM or the European database EUDAMED, serve as central collection points for relevant information that is essential for the market surveillance of medical devices. As soon as EUDAMED is fully functional, country-specific databases will be superfluous in the future. In addition to internal EU sources, the following are currently also of interest: MAUDE, Health Canada, IRIS of the TGA (Australia).
The systematic collection and evaluation of this data requires structured processes and technologies. Key elements include customer relationship management systems (CRM), incident reporting systems and business intelligence tools. These enable data to be collected, processed and analyzed in order to identify and address security risks.
A key challenge is to coordinate the multitude of information flows and translate them into useful findings. Cross-system interfaces and interdisciplinary communication channels must be established to ensure the integrity of the data and increase transparency. This enables manufacturers to take proactive measures and help ensure compliance with legal requirements.
Risk assessment and management
Risk management is an ongoing process that is an integral part of the quality management system in the development and manufacture of medical devices. In principle, risk assessment begins in the design phase of a medical device and extends throughout its entire life cycle.
Reliable risk analyses are the foundation for the safety of medical devices. The identification of hazards and risk assessment are essential steps to prevent potential harm to patients.
As part of post-market surveillance, the active collection of information on the use of products on the market is essential. This also includes the collection of findings from practical use in order to identify potential risks at an early stage and initiate measures to minimize risks.
Last but not least, systematic risk management is also crucial for compliance with regulatory requirements such as the EU Medical Device Regulation (MDR). In this context, manufacturers are obliged to continuously collect and evaluate data in order to ensure that safety and performance requirements are met throughout the entire product life cycle and to initiate corrective measures if necessary.
Methods of data collection
Continuous monitoring is essential for post-market surveillance. Various data collection methods are used to create a comprehensive safety profile of the medical devices.
Qualitative methods such as focus groups or expert interviews help to gather detailed feedback and in-depth insights. Quantitative approaches such as surveys and database analyses are also key to generating statistically valid findings and identifying trends.
In particular, the evaluation of incident reports and the analysis of customer satisfaction data are key elements of a successful post-market surveillance strategy. State-of-the-art analysis is also essential if you don’t want to miss the train to new technologies.
Feedback from end users
Feedback from end users is an integral part of post-market surveillance. It provides valuable insights into the practical use of medical devices and their handling in everyday life.
By collecting feedback in a targeted manner, manufacturers can identify comprehension problems, application errors and potential risks. Such information is essential to continuously improve the safety and effectiveness of products.
Analyzing end-user feedback makes it possible to increase user-friendliness and make product development more user-centric. This ensures that the products really do meet the needs and expectations of users.
Regular surveys and usability tests enable medical device manufacturers to collect meaningful data. This approach enables a timely response to end users’ experiences and the implementation of crucial improvements.
By integrating end users into the PMS process, manufacturers increase confidence in their products. At the same time, they promote transparency towards regulatory authorities and market players.
Analysis of complaints
The systematic investigation of complaints received is essential for the quality assurance of medical devices. Every complaint offers the opportunity to identify and systematically address potential for improvement.
By carefully documenting, analyzing and categorizing each complaint, a comprehensive picture of a product’s potential weaknesses is created. The resulting findings lead to preventive measures that can permanently increase the safety and reliability of the medical device. It is important that the manufacturer has established clear processes for dealing with customer feedback and that all employees are trained accordingly.
An effective analysis strategy also includes the monitoring of databases and forums in which users discuss products. This offers the opportunity to identify trends at an early stage and react to hidden defects before complaints become more frequent.
The analysis of complaints is an important pillar of this system and helps to ensure conformity with regulations, increase patient safety and strengthen user confidence in the product.
Monitoring of safety reports
The monitoring of safety reports is a fundamental component of the risk management process for medical devices. It serves to identify potential risks that could emanate from a product at an early stage.
In a dynamic market such as medical technology, the continuous monitoring and evaluation of safety reports is essential. As a manufacturer, you not only have to fulfill legal requirements – you also have a social responsibility towards users and patients. Proactive monitoring makes it possible to identify and address potential safety issues before incidents occur.
Safety reports can come from a variety of sources, from clinical studies and customer feedback to reports from doctors and professionals. The challenge is to efficiently collect, categorize and analyze this data in order to derive relevant safety information.
Against this backdrop, the systematic collection and analysis of safety reports plays a crucial role in post-market surveillance. The knowledge gained flows directly into quality assurance and product improvement. This ensures that medical devices meet the highest safety requirements throughout their entire life cycle and that end user confidence in the products is maintained.
Conclusion
The PMS covers various aspects, including the systematic collection and evaluation of data from various sources such as customer feedback, clinical studies and safety reports. This data is used to identify potential risks, increase product safety and make continuous improvements. Under the MDR and IVDR in particular, manufacturers are required to meet stringent PMS requirements, including regular safety reporting and continuous risk assessment.
An effective PMS system requires a systematic approach, integration of different data sources, a clear internal structure and regulatory compliance. By implementing an internal PMS system, companies can not only ensure the safety of their products, but also strengthen consumer confidence and improve their market position.
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